The present invention relates to pharmaceutical compositions and articles of manufacture useful in reversal of a clinical episode of an incurable disease and to methods of use thereof. More particularly, the present invention relates to use of passive immunization with an immune-globulin preparation as a mode of treatment for an acute attack of a disease. The present invention has demonstrable clinical efficacy in treatment of West Nile Virus and is expected to demonstrate similar utility in a wide variety of maladies which are generally considered incurable or irreversible.
The use of antibodies in medicine is well known. Antibodies may be employed to provide active immunity or passive immunity.
Active immunity is achieved by vaccination with a material that triggers an immune response in the vaccinated subject. The material is most often an antigen preparation, but may be an antigenic precursor or a nucleic acid sequence encoding an antigen(s). Active immunization often occurs naturally as a result of infection. Thus, a person that has suffered a clinical episode of chicken pox is unlikely to be re-infected with that the virus which caused their initial clinical episode. Administration of the material triggers the immune system of the subject to produce immune globulins which are specific to the antigen(s) in (or produced by) the administered material. All active immunization protocols have, as an inherent disadvantage, a strict requirement for an available source of antigen or antigenic precursor. Further, the antigen or antigenic precursor must typically be administered prior to presentation of clinical symptoms, preferably prior to infection.
Passive immunity is achieved via direct introduction of immune globulin molecules, or active portions thereof, into a subject. No immune response from the subject is required. Theoretically, passive immunization is possible for all diseases. In practice, use of passive immunization has been limited. This is because passive immunization typically requires purposeful preparation of immune globulins which is an inherent disadvantage. Further, passive immunization has most often been employed after exposure to a disease but prior to onset of clinical symptoms. The most well known examples of passive immunization is administration of anti-venom after a snake bite and use of immuno-globulins to prevent rabies infection in a person bitten by an animal at risk for rabies.
Banking of blood and blood components including fractions enriched in immunoglogulins is routinely carried out in many modern medical centers. Thus, there is no shortage of available immuno-globulins.
Despite the theoretical possibility of passive immunization, and despite the availability of immuno-globulins, many diseases are considered incurable or untreatable and result in morbidity and/or mortality of infected subjects. Because many of these diseases are fatal, it has always been assumed that the availability of immune globulins in the general population is low. Therefore, medical practitioners have failed to look in blood banks for available solutions which rely upon the well established principles of passive immunity. Further, because many of these diseases are transmissible via blood transfer, standard medical advice is to disqualify infected, or even exposed, individuals as blood donors. Thus, blood donors are typically required to answer a battery of questions designed to ascertain if they have ever been exposed to, for example, HIV, Lyme's disease, malaria or spongiform encephalopathy. Exposed individuals are typically disqualified as donors. This practice should, for all intents and purposes, ettectively eliminate immune globulin molecules with a specificity for antigens associated with infectious diseases from the blood supply.
There is thus a widely recognized need for, and it would be highly advantageous to have, pharmaceutical compositions and articles of manufacture useful in reversal of a clinical episode of an incurable disease and methods of use thereof.